Understanding the Effects of Pulmonary Arterial Hypertension on Lean Muscle Mass
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Chest Computed Tomographic (CT) scan
研究概览
简要总结
Patients with pulmonary arterial hypertension (PAH) are at increased risk of muscle loss and decreased physical activity. This study will aim to (1) understand the way in which muscle loss occurs in PAH, particularly the role of fat surrounding the heart, and (2) look at the impact muscle loss has on quality of life, daily physical activity, and hospitalizations in patients with PAH. The findings from this study could help identify potentially treatable factors that may improve the overall quality of life and physical functioning of patients with PAH.
Subjects will be asked to attend a baseline visit where the following will be performed:
- Measure your vital signs
- Undergo a research blood draw, less than 4 tablespoons
- Provide a urine pregnancy test (if applicable)
- Review demographics, personal history, and medical history
- Review current PAH medications
- Complete questionnaires on how your PAH affects you
- Complete a test of physical performance
- Complete a grip strength test
- Undergo an echocardiogram (Echo)
- Complete a six-minute walk test
- Undergo a Chest CT Scan
- Undergo a scan of your body composition (DXA scan)
- Obtain a weight and body composition measurement on the InBody Scale Subjects will also complete activity moniotring, two 24-hour diet recalls, and participate in remote follow-up visits every 6 months
详细描述
In a subset of patients, after obtaining informed consent, patients will be scheduled for an in-person visit with a physical therapist. The subject will have their vital signs checked, blood drawn and then will have the PortaMon device applied to their biceps and their calf muscles. The PortaMon is a wireless NIRS device designed to measure muscle oxygenation non-invasively. It has one channel to measure absolute oxygenated hemoglobin and three channels to measure relative concentrations of oxy-, deoxy-, total hemoglobin concentration changes, and tissue saturation index. Following application and activation of the biosensor and the NIRS device, the physical therapist will demonstrate the exercises to the participant and will observe them performing the exercises. After the conclusion of the session (~1.5 hours), the subject's vital signs will be reassessed and blood drawn. The second study visit will be at Week 12.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent prior to initiation of any study mandated procedure.
- •Diagnosis of PAH belonging to one of the following subgroups of Group 1 PH according to the updated clinical classification [Humbert 2022]
- •Idiopathic (IPAH)
- •Heritable (HPAH)
- •Drugs or toxins induced
- •Associated (APAH) with one of the following:
- •Connective tissue disease;
- •Human immunodeficiency virus (HIV) infection;
- •Congenital heart disease; or
- •Portopulmonary hypertension
- •Diagnosis of PAH within 6 months of enrollment or diagnosis of PAH and on stable therapy for 3 months prior to enrollment
- •Documented hemodynamic diagnosis of PAH by right heart catheterization (RHC), prior to enrollment showing:
- •mPAP > 20 mmHg; and
- •PAWP or LVEDP ≤ 15 mmHg
- •PVR > 2 Wood units
排除标准
- •Prior to enrollment, evidence of moderately severe obstructive ventilator defect with:
- •FEV1/FVC ≤ 5th percentile; and
- •FEV1 z-score < -2.5
- •Prior to enrollment, evidence of severe restrictive defect with
- •TLC < 5th percentile
- •FEV1 z-score < -4
- •Prior to enrollment, hospitalization (within 1 week) for decompensated right heart failure
- •More than moderate aortic or mitral valve disease
- •LVEF < 40% within 1 year of screening
- •Pregnancy
研究组 & 干预措施
PAH cohort at Penn and Brown
Participants will be asked to:
Complete a research blood draw Review of demographics, personal history, and medical history Review of current PAH medications Physical performance test (SPPB) Grip strength test Echocardiogram (Echo) Six-minute walk test Chest CT Scan Scan of your body composition (DXA scan) Wear an activity monitoring watch Complete 24-hour diet recall
干预措施: Chest CT scan (Radiation)
PAH cohort at Penn and Brown
Participants will be asked to:
Complete a research blood draw Review of demographics, personal history, and medical history Review of current PAH medications Physical performance test (SPPB) Grip strength test Echocardiogram (Echo) Six-minute walk test Chest CT Scan Scan of your body composition (DXA scan) Wear an activity monitoring watch Complete 24-hour diet recall
干预措施: blood draw (Diagnostic Test)
PAH cohort at Penn and Brown
Participants will be asked to:
Complete a research blood draw Review of demographics, personal history, and medical history Review of current PAH medications Physical performance test (SPPB) Grip strength test Echocardiogram (Echo) Six-minute walk test Chest CT Scan Scan of your body composition (DXA scan) Wear an activity monitoring watch Complete 24-hour diet recall
干预措施: Short Performance Physical Battery (Diagnostic Test)
PAH cohort at Penn and Brown
Participants will be asked to:
Complete a research blood draw Review of demographics, personal history, and medical history Review of current PAH medications Physical performance test (SPPB) Grip strength test Echocardiogram (Echo) Six-minute walk test Chest CT Scan Scan of your body composition (DXA scan) Wear an activity monitoring watch Complete 24-hour diet recall
干预措施: Grip strength test (Diagnostic Test)
PAH cohort at Penn and Brown
Participants will be asked to:
Complete a research blood draw Review of demographics, personal history, and medical history Review of current PAH medications Physical performance test (SPPB) Grip strength test Echocardiogram (Echo) Six-minute walk test Chest CT Scan Scan of your body composition (DXA scan) Wear an activity monitoring watch Complete 24-hour diet recall
干预措施: Six minute walk test (Diagnostic Test)
PAH cohort at Penn and Brown
Participants will be asked to:
Complete a research blood draw Review of demographics, personal history, and medical history Review of current PAH medications Physical performance test (SPPB) Grip strength test Echocardiogram (Echo) Six-minute walk test Chest CT Scan Scan of your body composition (DXA scan) Wear an activity monitoring watch Complete 24-hour diet recall
干预措施: Dual-Energy X-ray Absorptiometry Scan (Radiation)
PAH cohort at Penn and Brown
Participants will be asked to:
Complete a research blood draw Review of demographics, personal history, and medical history Review of current PAH medications Physical performance test (SPPB) Grip strength test Echocardiogram (Echo) Six-minute walk test Chest CT Scan Scan of your body composition (DXA scan) Wear an activity monitoring watch Complete 24-hour diet recall
干预措施: Activity monitoring (Behavioral)
PAH cohort at Penn and Brown
Participants will be asked to:
Complete a research blood draw Review of demographics, personal history, and medical history Review of current PAH medications Physical performance test (SPPB) Grip strength test Echocardiogram (Echo) Six-minute walk test Chest CT Scan Scan of your body composition (DXA scan) Wear an activity monitoring watch Complete 24-hour diet recall
干预措施: 24 hour diet recall (Behavioral)
PAH cohort at Penn and Brown
Participants will be asked to:
Complete a research blood draw Review of demographics, personal history, and medical history Review of current PAH medications Physical performance test (SPPB) Grip strength test Echocardiogram (Echo) Six-minute walk test Chest CT Scan Scan of your body composition (DXA scan) Wear an activity monitoring watch Complete 24-hour diet recall
干预措施: Echocardiogram (Diagnostic Test)
PAH cohort at Penn and Brown
Participants will be asked to:
Complete a research blood draw Review of demographics, personal history, and medical history Review of current PAH medications Physical performance test (SPPB) Grip strength test Echocardiogram (Echo) Six-minute walk test Chest CT Scan Scan of your body composition (DXA scan) Wear an activity monitoring watch Complete 24-hour diet recall
干预措施: Quality of Life Questionnaire (emPHasis 10) (Behavioral)
PAH cohort at Penn and Brown
Participants will be asked to:
Complete a research blood draw Review of demographics, personal history, and medical history Review of current PAH medications Physical performance test (SPPB) Grip strength test Echocardiogram (Echo) Six-minute walk test Chest CT Scan Scan of your body composition (DXA scan) Wear an activity monitoring watch Complete 24-hour diet recall
干预措施: International Physical Activity Questionnaire Short Form (IPAQ-SF) (Behavioral)
结局指标
主要结局
Chest Computed Tomographic (CT) scan
时间窗: One time at Baseline
The primary variables of interest will be total thoracic muscle volume measured on non-contrast chest CT scans
Adiponectin
时间窗: One time at Baseline
Measured using a solid phase sandwich ELISA (R\&D Systems, Inc., Minneapolis, MN) with a minimum detectable dose of 0.246 ng/mL and intra-assay variations (CV) 2.5%-4.7%.
Low lean mass
时间窗: One time at Baseline
Using the data from the dual-energy X-ray absorptiometry, we will generate fat mass index-adjusted appendicular lean mass index (ALMIFMI) Z-Scores derived from age, sex, and race/ethnicity specific models.16 Low lean mass will be defined as ALMIFMI ZScore less than or equal to -1.
Accelerometry measures
时间窗: One time at Baseline
Step counts and activity intensity (sedentary time, time spent doing light, moderate, and vigorous activity) will be derived.
Intake of food and nutrients
时间窗: One time at Baseline
Adequacy of micronutrient and protein intake are derived from the two 24 hour diets recalls.
Epicardial adipose tissue (EAT) volume
时间窗: One time at Baseline
Derived from chest CT
Metabolomics
时间窗: One time at Baseline
Circulating proteins will be measured in plasma samples using the Olink Proteomics (Waltham, MA). In this assay, Olink uses a proprietary proximity extension assay technology to combine a detection step involving oligonucleotide-labeled antibodies with a proximity-dependent DNA polymerization step and a real-time quantitative PCR amplification step to measure relative levels of multiple biomarkers simultaneously. Two different panels will be used: Olink Explore 384 Cardiometabolic and Olink Explore 384 Inflammation.
Right ventricular (RV) function
时间窗: One time at Baseline
Determined from 2D echocardiography
Health-Related Quality of Life (HRQOL)
时间窗: One time at Baseline
The emPHasis-10 is a questionnaire used to assess the impact of pulmonary hypertension (PH) on a person's life. It consists of 10 items, each scored on a scale of 0 to 5, resulting in a total score ranging from 0 to 50. Higher scores indicate a greater symptom burden and poorer quality of life.
次要结局
- Chest Computed Tomographic (CT) scan(One time at Baseline)